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Specifications

• Test TypeQualitative point-of-care test
• Assay MethodVisual dye colorization method
• InterpretationNormal vs. deficient
• SpecimenWhole blood
• Specimen Volume2 ㎕
• Result Time10 minutes
• Package Size25 or 50 tests/box
• Other Specifications Marked, Simple and easy to use, Broad range of assay temperature(18~32℃), Room temperature storage

G6PD deficiency

G6PD deficiency is a genetic disorder, resulting in no or low G6PD activity. People with G6PD deficiency should not take primaquine, an antimalarial drug, and other drugs with high oxidative stress because it could cause serious side effects such as acute hemolysis.

Features & Benefits

• True Point-Of-Care Test for G6PD with >95% Sensitivity * for WHO classification Ⅰ&Ⅱ (<10% of normal activity)
• CareStart™ G6PD RDT is a visual screening test that identifies G6PD deficient patients using whole blood sample.

Performance test result

Results of Access Bio's G6PD Performance Test :Institute Pasteur, Cambodi
	Cutoff Value(%)	<30%
CareStart™ G6PD RDT	Sensitivity (95% CL)	100%
	Specificity	97%

Source:

“A field trial to evaluate the performance of a point-of-care diagnostic for screening G6PD Deficiency in a falciparum and vivax malaria endemic area of Westem Cambodia.” American Society of Tropical Medicine and Hygiene (November, 2013)

Test Procedure

1

Gently hold the bottom part of the pipette and touch the blood drop with the open end of the capillary tube.(CAUTION : Do not cover the hole!)

2

Let the blood flow into the capillary tube.

3

Cover and press the hole to release the blood into the sample well. Add 2 drops of Assay Buffer (100㎕) immediay after to the buffer well.

4

Read result in 10 minutes.

 

Interpretation of the Test Result

NORMAL

A distinct purple color appears in the reading window within 10 min.

DEFICIENT

No color change or a very faint purple color appears in the reading window within 10 min(A borderline result is read as deficient.)

INVALID

No blood migration or incomplete blood migration in window.

Product	Cat. No.	Package Size	Components
CareStart™ G6PD RDT	RGP-M02582	25 tests/box	Alcohol, Lancets, Pipettes, Assay buffer, Instruction for use
	RGP-M05082	50 tests/box	Alcohol, Lancets, Pipettes, Assay buffer, Instruction for use